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 number (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 the user facility: after filling.1cc liquid into two a1 syringes, inspection revealed two monofilament foreign particles within both of the a1 syringes.On august 23, 2021, it was reported by customer compound preferred that the source of the blue monofilament objects originated from the a1 syringes.A photograph of an unopened a1 syringe reveals a similar strand within the sterile packaged 1cc syringe.

Event Description

As reported by the user facility: event 1: after filling.1cc liquid into two a1 syringes, inspection revealed two monofilament foreign particles within both of the a1 syringes.On august 23, 2021, it was reported by customer compound preferred that the source of the blue monofilament objects originated from the a1 syringes.A photograph of an unopened a1 syringe reveals a similar strand within the sterile packaged 1cc syringe.Correction: customer originally reported two (2) occurrences (one occurrence each with 2 batch numbers, b.Braun reference numbers (b)(4)), however further information was received that there were fourteen (14) occurrences with batch 21b11c8 but fifteen (15) samples were received.

Manufacturer Narrative

This report has been identified as b.Braun medical inc.Internal report number (b)(4), event 1.The investigation into this reported event is ongoing.A follow-up report will be submitted when the results of the investigation are available.

• Brand Name: NORM-JECT
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl- braun strabe 1; melsungen, 34212 ; GM 34212
• MDR Report Key: 12439857
• MDR Text Key: 270327661
• Report Number: 9610825-2021-00355
• 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: 09/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 21B11C8
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2021
• Initial Date Manufacturer Received: 08/23/2021
• Initial Date FDA Received: 09/08/2021
• Supplement Dates Manufacturer Received: 08/23/2021
• Supplement Dates FDA Received: 09/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1