MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE 1ML S/T W/NDL 26X5/8 RB; PISTON SYRINGE

Model Number 309597

Device Problem Complete Blockage (1094)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/02/2019

Event Type  malfunction  

Manufacturer Narrative

Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 9076761, medical device expiration date: 2024-02-29, device manufacture date: 2019-03-17, medical device lot #: 8221735, medical device expiration date: 2023-07-31, device manufacture date: 2018-08-09.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It has been reported that the bd¿ syringe 1ml s/t w/ndl 26x5/8 rb has been found experiencing two occurrences of clogged needles during use.The following has been provided by the initial reporter: it was reported that when the patient would draw back the needle to obtain medication, nothing would go through the needle.Patient tried twice with 2 different needles, and on the 3rd needle patient was able to draw up medication.It was reported: patient advised she was not able to draw up medication today with 2 needles.When patient would draw back needle to obtain medication, nothing would go through needle.Patient tried twice with 2 different needles, and on the 3rd needle patient was able to draw up medication.

Event Description

It has been reported that the bd¿ syringe 1ml s/t w/ndl 26x5/8 rb has been found experiencing two occurrences of clogged needles during use.The following has been provided by the initial reporter: it was reported that when the patient would draw back the needle to obtain medication, nothing would go through the needle.Patient tried twice with 2 different needles, and on the 3rd needle patient was able to draw up medication.It was reported: patient advised she was not able to draw up medication today with 2 needles.When patient would draw back needle to obtain medication, nothing would go through needle.Patient tried twice with 2 different needles, and on the 3rd needle patient was able to draw up medication.

Manufacturer Narrative

H.6.Investigation summary: no samples displaying the condition reported are available for examination, so we were unable to fully investigate this incident, therefore a root cause could not be determined.Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.

• Brand Name: BD SYRINGE 1ML S/T W/NDL 26X5/8 RB
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 9521779
• MDR Text Key: 193658824
• Report Number: 1213809-2019-01308
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903095972
• UDI-Public: 30382903095972
• Combination Product (y/n): N
• PMA/PMN Number: K980580
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 01/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 309597
• Device Catalogue Number: 309597
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other