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 2020-03-19 for BD SAFECLIP? 328235 manufactured by Becton Dickinson.
[186282547]
For oem manufacturing sites: in this mdr, bd corporate headquarters in (b)(4) has been listed as (b)(4) is an oem manufacturing site. Date of event: unknown. The date received by manufacturer has been used for this field. Medical device expiration date: n/a. Investigation summary: a complaint history check was performed and this is the 8th related complaint for not clipping (cutter blocked) on lot # 7177532. Customer returned a photo of a bd safe clip from lot # 7177532. Customer states that at the moment of introducing the needle to cut, it does not get into the hole, it looks like it is sealed, and sometimes the needle bends preventing the cut. The attached photo was examined and did not exhibit the cutting hole or show the ability of the sample to function. It is difficult to determine if the sample shown is able to function properly solely from the attached photo. According with the dhr review information above, the problem? No clipping? ,? Cutter blocked? And? Difficult or unable to operate? Has no nhb assembly process relation, all samples of safe clip disposable cutter (usa) passed functional test (sample plan c=0, aql=1). Based on the samples and/or photo(s) received the investigation concluded: unconfirmed: bd was not able to duplicate or confirm the customer? S indicated failure. 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 the above, no additional investigation and no capa is required at this time.
Patient Sequence No: 1, Text Type: N, H10
[186282548]
It was reported that the safe clip is jammed with an bd safeclip?. The following information was provided by the initial reporter, translated from spanish to english: patient's mother reports that for 20 to 30 days (there is no exact date), she has been having troubles with the safe-clip. At the moment of introducing the needle to cut, it does not get into the hole, it looks like it is sealed, sometimes the needle bends preventing the cut.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243072-2020-00454 |
| MDR Report Key | 9857745 |
| Report Source | CONSUMER,FOREIGN,OTHER |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-13 |
| Date of Event | 2020-03-12 |
| Date Mfgr Received | 2020-03-12 |
| Device Manufacturer Date | 2017-07-14 |
| Date Added to Maude | 2020-03-19 |
| 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 |
| Manufacturer Street | 1 BECTON DRIVE |
| Manufacturer City | FRANKLIN LAKES NJ 07417 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 07417 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BD SAFECLIP? |
| Generic Name | HYPODERMIC SINGLE LUMEN NEEDLE |
| Product Code | FMI |
| Date Received | 2020-03-19 |
| Model Number | 328235 |
| Catalog Number | 328235 |
| Lot Number | 7177532 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON DICKINSON |
| Manufacturer Address | 1 BECTON DRIVE FRANKLIN LAKES NJ 07417 US 07417 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-19 |