MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,other report with the FDA on 2020-03-20 for NEEDLE 26X3/8 IB 305110 manufactured by Bd Medical (bd West) Medical Surgical.
[186321155]
(b)(6). Investigation summary: no sample was received. No photo was provided. Since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident. No root cause can? T be determined as no samples were received. 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. Based on no sample, the investigation concluded, bd was not able to verify the indicated failure. 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 # 9234180 for this type of defect or symptom. There was no documentation for this type of defects 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
[186321156]
It was reported that the needle 26x3/8 ib experienced a needle hub hole/crack/damage. Product defect was noted prior to use. The following information was provided by the initial reporter: material no. : 305110 batch no. : 9234180. Description of issue: customer called to report needle was cracked around the base of the needle. Number of occurrences: 1. Did the customer insert the needle into the cartridge and encounter fill resistance? No. Proceed to step 4. Item number choose one: bd 26 g, 3/8? Needle? 305110, product lot number: 9234180, for bd product only, are samples available for investigation, no. Did issue cause any injury? If yes, what type of injury? No. Medical intervention needed? If yes, who was the 3rd party and what was the assistance/treatment? No. Resolution: customer switched out syringe and needle and successfully loaded a cartridge.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1911916-2020-00283 |
| MDR Report Key | 9862651 |
| Report Source | DISTRIBUTOR,OTHER |
| Date Received | 2020-03-20 |
| Date of Report | 2020-03-17 |
| Date of Event | 2020-02-17 |
| Date Mfgr Received | 2020-03-13 |
| Device Manufacturer Date | 2019-08-22 |
| 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 | 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 26X3/8 IB |
| Generic Name | HYPODERMIC SINGLE LUMEN NEEDLE |
| Product Code | FMI |
| Date Received | 2020-03-20 |
| Model Number | 305110 |
| Catalog Number | 305110 |
| Lot Number | 9234180 |
| 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 | 2020-03-20 |