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U.S. Department of Health and Human Services

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

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B. BRAUN MELSUNGEN AG NORM-JECT; SYRINGE, PISTON Back to Search Results
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.
 
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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 Key12439857
MDR Text Key270327661
Report Number9610825-2021-00355
Device Sequence Number1
Product Code FMF
UDI-Device Identifier04046955596911
UDI-Public(01)04046955596911
Combination Product (y/n)N
PMA/PMN Number
K063280
Number of Events Reported1
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 NumberNJ-9166017-02
Device Catalogue NumberNJ-9166017-02
Device Lot Number21B11C8
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/02/2021
Initial Date Manufacturer Received 08/23/2021
Initial Date FDA Received09/08/2021
Supplement Dates Manufacturer Received08/23/2021
Supplement Dates FDA Received09/14/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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