MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-04-06 for BOJECT NEEDLE 9013S0442 manufactured by Alpine Biomed Aps.
[71829585]
The information provided below represents all of the known information at this time. The lot history record will be reviewed with special attention to the manufacturing and inspection of this product. Customer has been contacted via email to obtain outstanding information in relation to the below sections: patient identifier: awaiting response from customer. Age at the time of event, date of birth - awaiting response from customer. Relevant tests/laboratory data, including dates - not applicable. Other relevant history, including preexisting medical conditions (e. G. , allergies, race, pregnancy, smoking and alcohol use, hepatic/renal dysfunction, etc. ) - not applicable. Concomitant medical products and therapy dates (excludes treatment of event) - not applicable. Justification for not providing below information and applicable sections: serial # - this section is not applicable as the medical device does not have serial #. Unique identifier (udi) # - this section is not applicable as the medical device did not have the udi# present on the labelling at the time of manufacture. If implanted date (mm/dd/yyyy) - this section is not applicable as the medical device is not implantable. If explanted date (mm/dd/yyyy) - this section is not applicable as the medical device is not implantable. Reprocessor name and address - this section is not applicable as the medical device is not a single-use device that was reprocessed or reused on a patient. If ind, give protocol # - this section is not applicable as the medical device is not ind. Adverse event term(s) - this section is not applicable to medical devices. If remedial action initiated, check type - this section is not applicable as no remedial action was initiated. If action reported to fda under 21 usc 360i (f), list correction/removal reporting number - this is not applicable as there was no action reported under 21 usc 360i (f). Customer has also been contacted to advise on the patient health status and the outcome of the surgery. Corrected data alpine biomed aps is submitting this report under manufacturer's report # 3004827015-2017-00002. Information in this report has been previously submitted under the initial report_3005581270-2017-00003. Incorrect manufacturer's establishment number for the manufacturing site of the reported device has been submitted. The correct manufacturer's establishment number for the manufacturing site of the reported device is (b)(4) this report reflects the information already submitted in the report referenced above. (b)(6). Address of the manufacturer reporting site has been corrected to alpine biomed (b)(4). Type of reportable event corrected from malfunction to serious injury. Not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[71829586]
Translation of customer report: the needle had twisted several times before because the patient was moving, the brain injury that he presents causing a lack of control of the reflexes, his muscles are deep and powerful because it makes 93 kg for 185 cm. The fact that the needle twists did not worry me because it is very thin (37 mm x 0. 41 mm, 27 g) and this has already happened to me without consequence. This time the needle broke when it was inserted into its support and when i pulled out the pressure on the muscle it was buried in the muscle, i could not remove it, it will be removed at the operating room of the clinic of (b)(6) by dr. (b)(6) on monday (b)(6).
Patient Sequence No: 1, Text Type: D, B5
[74276548]
Manufacturer narrative: patient experienced fatigue after the surgery which he attributed to general anesthesia. Patient reminded in the hospital for further 15 hours after the surgery. Patient has been released 15 days after the scheduled date. He had been able to gradually resume his physiotherapy since it had taken a little delay because of the undesirable event. It is not expected that the patient will revisit the surgeon and he has not had any specific treatment after surgery, other than a wound care. Inspection was carried out on this batch on the 23rd june 16 using incoming inspection form, batch release certificate and sterilization release checklist. These completed forms were reviewed with no non conformances noted. Certification of compliance present with signature and date. The dhr related to this lot was received from the contract manufacturer. On review of this there were no non conformances noted. The result of the investigation is inconclusive as the device was not returned for evaluation. Based on the feedback received from customer the weight has been corrected from (b)(6). Based on the feedback received from customer the type of reportable event has been corrected from malfunction to serious injury as patient required further surgery. ''unique identifier (udi) # this section is not applicable as the medical device did not have the udi# present on the labelling at the time of manufacture'' has been corrected and udi# provided in initial report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004827015-2017-00002 |
| MDR Report Key | 6463178 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-04-06 |
| Date of Report | 2017-02-23 |
| Date of Event | 2017-02-22 |
| Date Mfgr Received | 2017-04-11 |
| Device Manufacturer Date | 2016-06-01 |
| Date Added to Maude | 2017-04-06 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PHARMACIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. MICHAEL GALVIN |
| Manufacturer Street | TONSBAKKEN 16-18 |
| Manufacturer City | SKOVLUNDE, DK-2740 |
| Manufacturer Country | DA |
| Manufacturer Postal | DK-2740 |
| Manufacturer Phone | 3539164745 |
| Manufacturer G1 | BIOENGINEERING LABORATORIES SRL |
| Manufacturer Street | VIA CESARE CATTANEO, 20 CANT |
| Manufacturer City | COMO, 22063 |
| Manufacturer Country | IT |
| Manufacturer Postal Code | 22063 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BOJECT NEEDLE |
| Generic Name | DISPOSABLE HYPODERMIC NEEDLE, |
| Product Code | IKT |
| Date Received | 2017-04-06 |
| Model Number | 9013S0442 |
| Catalog Number | 9013S0442 |
| Lot Number | N-2016-06-009 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALPINE BIOMED APS |
| Manufacturer Address | TONSBAKKEN 16-18 SKOVLUNDE, DK 2740 DA DK 2740 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other; 3. Required No Informationntervention | 2017-04-06 |