MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2018-06-22 for INTROCAN? SAFETY N/A 4251628-03 manufactured by B. Braun Melsungen Ag.
[112428917]
(b)(4) device history record review (dhr): reviewed the device history record and no abnormalities found during in- process and final control inspection. Investigation results: received 1 used contaminated cannula hub of introcan safety pur 22g, 0. 9x25mm-ap without packaging. Capillary hub was not returned for investigation. The safety clip was in an engaged position. The returned sample was examined under a smartscope. No damages were observed on the safety clip and crimp area on the cannula. The safety clip was not deformed. No abnormality found in crimping area. Simulation for clip function: pushed back the safety clip to the cannula hub. Inserted the returned sample with a fresh capillary hub of g22 to simulate the clip function. After withdrawal, the safety clip was activated and able to cover cannula tip. Conclusion: the returned sample was tested and not abnormality observed. Dhr reviewed showed no deviation and the complaint batch passed clip functional test and visual inspection. Complaint is not confirmed.
Patient Sequence No: 1, Text Type: N, H10
[112428918]
As reported by the user facility (translation of user facility information by bbm sales organization in (b)(4): needlestick injury (safety clip failure).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610825-2018-00113 |
| MDR Report Key | 7629321 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2018-06-22 |
| Date of Report | 2018-06-22 |
| Date of Event | 2018-05-29 |
| Date Facility Aware | 2018-06-21 |
| Report Date | 2018-06-22 |
| Date Reported to FDA | 2018-06-22 |
| Date Reported to Mfgr | 2018-06-22 |
| Date Mfgr Received | 2018-05-30 |
| Device Manufacturer Date | 2016-11-16 |
| Date Added to Maude | 2018-06-22 |
| 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 | MR. JONATHAN SEVERINO |
| Manufacturer Street | 901 MARCON BLVD. |
| Manufacturer City | ALLENTOWN 18109 |
| Manufacturer Country | US |
| Manufacturer Postal | 18109 |
| Manufacturer Phone | 4847197287 |
| Manufacturer G1 | B. BRAUN MELSUNGEN AG |
| Manufacturer Street | CARL-BRAUN-STR. 1 |
| Manufacturer City | MELSUNGEN, 34212 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 34212 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INTROCAN? SAFETY |
| Generic Name | I.V. SAFETY CATHETER |
| Product Code | DQR |
| Date Received | 2018-06-22 |
| Returned To Mfg | 2018-06-06 |
| Model Number | N/A |
| Catalog Number | 4251628-03 |
| Lot Number | 16M16G8362 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | B. BRAUN MELSUNGEN AG |
| Manufacturer Address | CARL-BRAUN-STR. 1 MELSUNGEN, HESSEN 34212 GM 34212 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-06-22 |