MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD 1ML LS SYRINGE

Catalog Number 303172

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 09/29/2021

Event Type  malfunction  

Manufacturer Narrative

Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that 2 bd 1ml ls syringes experienced difficulty connecting the syringe to the mating component.The following information was provided by the initial reporter, translated from (b)(6) to english: the customer uses this product for covid-19 vaccination (pfizer).According to the customer's report, the connection between bd's syringe and non-bd's needle was loose.

Event Description

It was reported that 2 bd 1ml ls syringes experienced difficulty connecting the syringe to the mating component.The following information was provided by the initial reporter, translated from japanese to english: the customer uses this product for covid-19 vaccination (pfizer).According to the customer's report, the connection between bd's syringe and non-bd's needle was loose.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2021-12-01.H6: investigation summary : two syringes and photos received for investigation, upon visual inspection of the two syringes received no molding damage like burrs can be noticed that can affect the geometry of the tip of the syringe.Luer cone fitting verification testing performed, no defects were identified.The lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.To perform further investigations, samples from tochigi seiko needles were requested to evaluate them.Needles provided were evaluated with a pass/no pass iso gauge.Samples do not meet specification.Hub of the used needle is short not meeting iso specification.Non iso compliant needles provided by customer suggest the root cause of the defect could be related with the dimensions of the hub of the needle.Based on the quality team's investigation, we are not able to identify a root cause related to our manufacturing process at this time.

• Brand Name: BD 1ML LS SYRINGE
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer (Section G): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12712909
• MDR Text Key: 279585722
• Report Number: 3003152976-2021-00711
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/14/2021

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: Other
• Device Catalogue Number: 303172
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/29/2021
• Initial Date FDA Received: 10/28/2021
• Supplement Dates Manufacturer Received: 12/14/2021
• Supplement Dates FDA Received: 01/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1