MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG NORM-JECT; SYRINGE, PISTON

Model Number NJ-9166017-02

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

This report has been identified as b.Braun medical inc.Internal report (b)(4).The investigation into this reported event is ongoing.A follow-up report will be submitted when the results of the investigation are available.

Event Description

As reported by user facility: detected what appeared to be spider on the exterior tip of an unused syringe within the sterile packaging.

Manufacturer Narrative

This report has been identified as b.Braun medical inc.Internal report number (b)(4).The actual device involved in the reported incident was not returned, however a photo was provided for evaluation.Upon examination of the provided photo, the manufacturer did confirm that there was some kind of foreign material present.Since the actual device was not returned, the foreign material could not be tested to determine if the material was a spider or insect, or some other foreign material from the manufacturing process.As a result, no specific conclusions on the root cause can be drawn.Review of the device history record performed for the reported lot number did not reveal any abnormalities or non-conformances of this nature.If additional pertinent information becomes available a follow-up report will be filed.

• Brand Name: NORM-JECT
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen, hessen 34212 ; GM 34212
• MDR Report Key: 11709190
• MDR Text Key: 256866933
• Report Number: 9610825-2021-00132
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 04046955596911
• UDI-Public: (01)04046955596911
• Combination Product (y/n): N
• PMA/PMN Number: K063280
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 06/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NJ-9166017-02
• Device Catalogue Number: NJ-9166017-02
• Device Lot Number: 21A04C8
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1