MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2016-06-06 for ICP LUER ADAPTOR 16-1057 manufactured by Codman & Shurtleff, Inc..
[46588138]
(b)(4). Upon completion of the investigation a follow up report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[46588139]
On (b)(6) 2016, the rep informed me of a leakage problem occurring at the connector between the bactiseal evd catheter 82-1745 and the codman reference 821731 external drainage system eds3. The connector = codman item 16-1057. Even though the 821731 was connected carefully to the 161057, a crack in the female luer lock connector part was observed. Another 161057 had to be connected to make the connection between the 821745 catheter and the 821731 drainage system. A similar problem was already communicated in the past (complaint dd 14 aug 2014; (b)(4)). On 5/24/2016 per affiliate: the problem was not seen as "intra-operatively" as the patient was already on the intensive care department. The surgeon mentioned the leaking because air had come into the drain by which a fluid coupled transducer was connected (by a three-way valve of the associated collecting system 821731). Therefore the intracranial pressure also wasn't well measured. The patient didn't seem to have caught up some consequences, but the surgeon is in these cases always apprehensive for infections (cave meningitis). The defective white connector was removed and replaced by a connector which was enclosed to the bactiseal evd catheter (reference 821749). This is a large lumen catheter. The connector is similar to the 161057 but is transparent instead of white and have some small differences in his configuration. This transparent connector isn't available separately. The replacement of the connector didn't took that long, however it took some time to find this replacing element (1. 5h). May we also kindly indicate that this surgeon also already raised this complaint before ((b)(4)) and she doesn't have the feeling that a lot has been done in order to avoid this problem in the future. This is something she regrets. She also regrets it that the transparent connector which belongs to the 821749 catheter isn't available on its own. Furthermore there has also been another same like complaint from this hospital which was raised by the pharmacist. This was (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[53566934]
The device was returned and evaluated. The lot number of the device was not provided; therefore, we were not able to review the manufacturing records of this device or determine whether there have been similar complaints against this lot. Evaluation of the returned device found that it had appeared to separate along the mold parting lines. The device failed a leak test. While the reported issue was confirmed, we were unable to determine the direct cause of failure based on the device as it was returned. While no lot number was provided, a review of all complaints against this part number over the last 12 months did not reveal any similar complaints. Trends will be monitored for this or similar complaints. At present, we consider this complaint to be closed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226348-2016-10405 |
| MDR Report Key | 5700550 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-06-06 |
| Date of Event | 2016-05-20 |
| Date Mfgr Received | 2016-08-22 |
| Date Added to Maude | 2016-06-06 |
| 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 | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR JAMES KENNEY |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 5088282726 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ICP LUER ADAPTOR |
| Generic Name | INTRACRANIAL CANNULA |
| Product Code | HCD |
| Date Received | 2016-06-06 |
| Returned To Mfg | 2016-05-31 |
| Catalog Number | 16-1057 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CODMAN & SHURTLEFF, INC. |
| Manufacturer Address | 325 PARAMOUNT DRIVE RAYNHAM MA 02767 US 02767 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-06-06 |