MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-11 for 3 ML BD POSIFLUSH? HEPARIN LOCK FLUSH SYRINGE, 30 USP UNITS/3 ML 306413 manufactured by Bd Medical (bd West) Medical Surgical.
[119922974]
No samples were provided for evaluation. There was no documentation of issues for the complaint of this batch # during this production run. All our inspections performed while manufacturing this batch # was accepted; no rejections were documented. Controls in place at the manufacturing site: - bioburden tested on a weekly basis. - an overkill sterilization process is used. - environmental testing within the filling area is done on a biweekly basis. - the sterilization process is challenged and re-qualified annually. - the solution is filtered twice before it is filled in syringes (note: once when transferring to the hold tank and again at the fill machine). - endotoxin testing is performed on each batch. - fill room operators are trained and qualified on gowning for the fill room environment on an annual basis. - weekly bioburden testing on the components used to assemble the syringes. - continuous online monitoring of the wfi (water for injection) water quality (note: this is for toc (total organic carbon) and conductivity, not microbial. - weekly bioburden and endotoxin testing of the (b)(4) purified water and wfi systems. - weekly endotoxin testing of the pure steam system. - each sterilizer is thoroughly validated before use for posiflush sterilization. Complaints received for this device and reported condition will continue to be tracked and trended. Information will be captured on trend reports and monitored monthly. Our business team regularly reviews the collected data for identification of emerging trends. Investigation conclusion: this is the first complaint for lot # 814601n for this type of defect or symptom. There was no documentation of issues for the complaint of batch # 814601n during this production run. Root cause description: undetermined.
Patient Sequence No: 1, Text Type: N, H10
[119922975]
A patient's son reported that his father passed away on (b)(6) 2018. The cause of death was reported as a heart attack related to a blood clot. The patient also had a history of septic shock, (b)(6) from gangrene in (b)(6) and (b)(6), a partial foot amputation, a heart attack three months prior to his death with one stent placed in his left leg and two stents placed in his heart, and was hospitalized for one month. The patient's son indicated that these events occurred while the patient was using a 3 ml bd posiflush? Heparin lock flush syringe, 30 usp units/3 ml (10 usp units/ml).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1911916-2018-00530 |
| MDR Report Key | 7866934 |
| Date Received | 2018-09-11 |
| Date of Report | 2018-09-05 |
| Date of Event | 2018-08-24 |
| Date Mfgr Received | 2018-08-24 |
| Device Manufacturer Date | 2018-05-25 |
| Date Added to Maude | 2018-09-11 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | BDX BRETT WILKO |
| Manufacturer Street | 9450 SOUTH STATE STREET |
| Manufacturer City | SANDY UT 84070 |
| Manufacturer Country | US |
| Manufacturer Postal | 84070 |
| Manufacturer Phone | 8015652845 |
| Manufacturer G1 | BD MEDICAL (BD WEST) MEDICAL SURGICAL |
| Manufacturer Street | 1852 10TH AVENUE |
| Manufacturer City | COLUMBUS NE 68601 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 68601 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | 3 ML BD POSIFLUSH? HEPARIN LOCK FLUSH SYRINGE, 30 USP UNITS/3 ML |
| Generic Name | PREFILLED HEPARIN FLUSH SYRINGE |
| Product Code | NZW |
| Date Received | 2018-09-11 |
| Catalog Number | 306413 |
| Lot Number | 814601N |
| Device Expiration Date | 2019-11-30 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BD MEDICAL (BD WEST) MEDICAL SURGICAL |
| Manufacturer Address | 1852 10TH AVENUE COLUMBUS NE 68601 US 68601 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death; 2. Hospitalization; 3. Required No Informationntervention | 2018-09-11 |