MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,other report with the FDA on 2020-02-28 for NEEDLE FILTER BLUNT FILL 18X1-1/2 305211 manufactured by Bd Medical (bd West) Medical Surgical.
[187221892]
Date of event: unknown. The date received by manufacturer has been used for this field. Investigation summary: 1 photo was provided. It shows a packaging blister with the top web, it is torn on the bottom part of the needle assembly; the plastic needle hub is visible. It looks like the part was opened by pushing the needle assembly and getting torn the top web instead of pulling apart the bottom-top web. While the symptom is confirmed; it is unclear how this damaged happened. 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. A device history record review was completed with zero defects found. No quality notifications were written for this batch, nor for the associated assembly batches. Investigation conclusion: this is the 1st complaint for lot # 8206851 for this type of defect or symptom. There was no documentation for this type of defect during the entire production run of this batch. Root cause description: undetermined. Rationale: capa not required at this time
Patient Sequence No: 1, Text Type: N, H10
[187221893]
It was reported that an unspecified number of needle filter blunt fill 18x1-1/2 experienced a damaged or open unit package/seal where the sterility of the product is compromised. Product defect was noted prior to use. The following information was provided by the initial reporter: i? M writing because a notification on batch 8206851 of filter needles 18g code k272200 has been received. The claim is related to a torn needle pocket.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1911916-2020-00200 |
| MDR Report Key | 9772166 |
| Report Source | COMPANY REPRESENTATIVE,OTHER |
| Date Received | 2020-02-28 |
| Date of Report | 2020-02-25 |
| Date of Event | 2020-02-24 |
| Date Mfgr Received | 2020-02-24 |
| Device Manufacturer Date | 2018-07-25 |
| Date Added to Maude | 2020-02-28 |
| 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 | 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 | 3 |
| Brand Name | NEEDLE FILTER BLUNT FILL 18X1-1/2 |
| Generic Name | MANUAL SURGICAL INSTRUMENT FOR GENERAL USE |
| Product Code | GAA |
| Date Received | 2020-02-28 |
| Model Number | 305211 |
| Catalog Number | 305211 |
| Lot Number | 8206851 |
| 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. Other | 2020-02-28 |