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 PEN NEEDLE 32GX4MM 14 PACK 329491 manufactured by Bd (suzhou).
[187895514]
Investigation summary: lot#: 8089411 dhr was reviewed and no qn found. Manufacture records were reviewed, no abnormal was found. 14pcs retention samples were checked the leakage through clog test, there is no leakage detected, the water was flowed through the cannula tip which is meet requirement. No returned samples or actual defect samples for investigation, so we can? T performing in-depth investigation. Investigation conclusion: however, we will keep monitor on similar issue from filed and trending regularly. Root cause description: based on the investigation above, the certain cause cannot be concluded at the moment. Rationale: the severity of leakage is moderate (s3), the occurrence of pen needle leakage complaint rate is <1 cpm(o1) since from 2017. The risk level is low, no need to open capa.
Patient Sequence No: 1, Text Type: N, H10
[187895515]
It was reported that pen needle 32gx4mm 14 pack leaked during use. This occurred on 3 occasions. The following information was provided by the initial reporter: the client had used bd needles for more than 20 years, and used 4mm needles for more than one year. In (b)(6), he bought two boxes of 14 needles when he was hospitalized in rehabilitation center. On the morning of (b)(6), after the injection, all liquid was flowed out, there were three times injection into the body, at night they used the same needle to do the injection, when pulled out the body, the liquid also flowed out, the liquid after the replacement of a new needle, also had liquid flowed out, on 3. 8, the injection replaced with three parts, and stayed for more than 15 seconds to pull out. After each injection, it also had liquid overflow condition, customer wanted to know the reason. The two needles in the evening were reserved and it could be returned for investigation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006948883-2020-00091 |
| MDR Report Key | 9857683 |
| Report Source | CONSUMER,FOREIGN,OTHER |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-09 |
| Date of Event | 2020-03-08 |
| Date Mfgr Received | 2020-03-08 |
| Device Manufacturer Date | 2018-09-08 |
| 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 | BD (SUZHOU) |
| Manufacturer Street | NO. 5 BAIYU ROAD SUZHOU INDUSTRIAL PARK |
| Manufacturer City | SUZHOU |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PEN NEEDLE 32GX4MM 14 PACK |
| Generic Name | PEN NEEDLE |
| Product Code | FMI |
| Date Received | 2020-03-19 |
| Catalog Number | 329491 |
| Lot Number | 8089411 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BD (SUZHOU) |
| Manufacturer Address | NO. 5 BAIYU ROAD SUZHOU INDUSTRIAL PARK SUZHOU |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-19 |