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 2019-03-19 for INTROCAN? SAFETY 4254538-020 4254538-03 manufactured by B. Braun Melsungen Ag.
[139345238]
(b)(4). This report has been identified as b. Braun (b)(4). Although the batch number of the item involved in the reported incident is unknown, two potential batches were reported, 18d18g8301 and 18d09g8303. A dhr review was performed for each of the reported batches. Device history record (dhr): reviewed the dhr, there are no abnormalities found during in process and final control inspection. Sample for evaluation: received 1 used contaminated capillary hub of introcan safety-w fep 20g, 1. 1x32mm-ap without packaging. Attached with the returned sample was a luer connector, presumably the customer used with the introcan safety. The cannula hub and protective cap were not returned for investigation. Investigation results: visual inspection observed the capillary was torn off approximately 7mm from the capillary hub horn. Torn off piece of the capillary was not returned for investigation. The torn area had an uneven shape like it has been clamped. The root cause potentially due to application fault. Complaint is not confirmed. Note: this report is being filed as both a product problem and an adverse event due to the fact that the tip of the catheter may have remained in the patient. No intervention was done, and currently there is no serious injury to the patient, so this report has been classified only as a malfunction.
Patient Sequence No: 1, Text Type: N, H10
[139345239]
As reported by the user facility (translation of user facility information by (b)(4): broken catheter tip.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610825-2019-00076 |
| MDR Report Key | 8432813 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2019-03-19 |
| Date of Report | 2019-07-03 |
| Date of Event | 2019-02-10 |
| Date Facility Aware | 2019-03-19 |
| Report Date | 2019-07-03 |
| Date Reported to FDA | 2019-07-03 |
| Date Reported to Mfgr | 2019-07-03 |
| Date Mfgr Received | 2019-02-21 |
| Date Added to Maude | 2019-03-19 |
| 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 | MR. JONATHAN SEVERINO |
| Manufacturer Street | 861 MARCON BLVD. |
| Manufacturer City | ALLENTOWN PA 18109 |
| Manufacturer Country | US |
| Manufacturer Postal | 18109 |
| Manufacturer Phone | 4842408332 |
| 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 | 2019-03-19 |
| Returned To Mfg | 2019-03-01 |
| Model Number | 4254538-020 |
| Catalog Number | 4254538-03 |
| Lot Number | UNKNOWN |
| 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 | 1. Other | 2019-03-19 |