MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign,other report with the FDA on 2020-03-20 for PEN NDL 32G 4MM PRO 14 BAG 700 CASE JPX 320559 manufactured by Becton Dickinson And Co..
[186306400]
Date of event: unknown. The date received by manufacturer has been used for this field. Device expiration date: unknown. Investigation summary: no samples or photos were returned for analysis. Investigation conclusion: no dhr review can be carried out as lot number is unknown. Rationale: based on an evaluation of severity and occurrence it was determined that no corrective action is required at this time. Device manufacture date: unknown.
Patient Sequence No: 1, Text Type: N, H10
[186306401]
It was reported that an unspecified number of pen ndl 32g 4mm pro 14 bag 700 case jpx experienced the cannula breaking off on the patient and non patient end. Product defects were noted during use. The following information was provided by the initial reporter: a patient changed from a competitor's product to micro fine pro. Then needle pe and npe breakage occurs often.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616656-2020-00246 |
| MDR Report Key | 9861748 |
| Report Source | CONSUMER,FOREIGN,OTHER |
| Date Received | 2020-03-20 |
| Date of Report | 2020-03-05 |
| Date of Event | 2020-03-04 |
| Date Mfgr Received | 2020-03-04 |
| Date Added to Maude | 2020-03-20 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 8015652341 |
| Manufacturer G1 | BECTON DICKINSON AND CO. |
| Manufacturer Street | POTTERY ROAD |
| Manufacturer City | DUN LAOGHAIRE CO |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PEN NDL 32G 4MM PRO 14 BAG 700 CASE JPX |
| Generic Name | PEN NEEDLE |
| Product Code | FMI |
| Date Received | 2020-03-20 |
| Catalog Number | 320559 |
| Lot Number | UNKNOWN |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON DICKINSON AND CO. |
| Manufacturer Address | POTTERY ROAD DUN LAOGHAIRE CO |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-20 |