MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-31 for BD POSIFLUSH? HEPARIN LOCK FLUSH SYRINGE 306424 manufactured by Bd Medical (bd West) Medical Surgical.
[115773103]
Date of event: unknown. Investigation summary: three samples were received. They have sealed packaging flow wrap, the plunger rod-rubber stopper, the tip cap. The barrel labels show the lot#811686n. The batch records for lot# 811686n were reviewed finding no documentation of issues for the complaint during this production run. Visual inspection of the three (3) samples was performed finding no discoloration/ variation of color nor cloudy. The lab performed testing for appearance and solution clarity and endotoxin. Results show products passed. This product has a barrel label with a section of yellow color as well as yellow tip cap, it is possible the reflection of the yellow color has induced the concerns expressed by the customer. This is the first complaint for the lot# 807864n for the same defect or symptom. There was no documentation of issues for the complaint of batch 807864n during this production run. Root cause description: undetermined. Rationale: capa not necessary.
Patient Sequence No: 1, Text Type: N, H10
[115773104]
It was reported that the barrel of the bd posiflush? Heparin lock flush syringe was opaque, making it impossible to determine if the heparin inside was clear or cloudy. This made the user extremely uncomfortable using these syringes due to the possibility of injecting contaminated fluid into the patient. There was no report of exposure, injury, or medical intervention noted.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1911916-2018-00417 |
| MDR Report Key | 7736859 |
| Date Received | 2018-07-31 |
| Date of Report | 2018-09-04 |
| Date of Event | 2018-07-09 |
| Date Mfgr Received | 2018-07-09 |
| Device Manufacturer Date | 2018-03-19 |
| Date Added to Maude | 2018-07-31 |
| 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 | BD POSIFLUSH? HEPARIN LOCK FLUSH SYRINGE |
| Generic Name | INTRAVASCULAR CATHETER |
| Product Code | NZW |
| Date Received | 2018-07-31 |
| Returned To Mfg | 2018-07-18 |
| Catalog Number | 306424 |
| Lot Number | 807864N |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | BD MEDICAL (BD WEST) MEDICAL SURGICAL |
| Manufacturer Address | 1852 10TH AVENUE COLUMBUS NE 68601 US 68601 |
| Brand Name | BD POSIFLUSH? HEPARIN LOCK FLUSH SYRINGE |
| Generic Name | INTRAVASCULAR CATHETER |
| Product Code | NZW |
| Date Received | 2018-07-31 |
| Returned To Mfg | 2018-07-18 |
| Catalog Number | 306424 |
| Lot Number | 807864N |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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. Other | 2018-07-31 |