MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD¿ SYRINGE

Catalog Number 301942

Device Problem Gas/Air Leak (2946)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/29/2018

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that air leaked into the bd¿ syringe barrel during blood withdrawal.There was no report of exposure, injury, or medical intervention noted.

Event Description

It was reported that air leaked into the bd syringe barrel during blood withdrawal.There was no report of exposure, injury, or medical intervention noted.

Manufacturer Narrative

Due to an it issue beginning on (b)(6) 2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: other; device single use?: no; device returned to manufacturer: yes.

Manufacturer Narrative

Investigation summary: we have been provided with the affected samples.A leakage through the plunger rod was observed in the provided samples.We could not determine the exact root cause due to the presence of dry blood inside the syringes.The samples were not decontaminated.We have reviewed our production and inspection records and have established that all production and quality processes were carried out normally.Neither qn nor ncmr's.Syringes were packed in machine nº2020 (november 14th - 16th, 2017).Syringes were assembled in machines nº4255, nº4254, nº4237, nº4236, and nº4220, in lot #7317654 (november 13th - 20th, 2017).Research has found no problems, defects or qn related to the reported issue.We have also reviewed the barrel lot #7318864, #7311693, #7296611, and no problems, defects or qn were found.We have also reviewed the plunger lots #7318868, #7311697, #7296627, and no problems, defects or qn were found.After the evaluation of the received sample, we conclude that the possible cause of the problem could be produced as a consequence of a damage in the plunger lip.This could be produced during the handling of the product through the manufacturing process or in the plunger assembly machine.Not able to determine.Damage in the plunger lip produced during the handling of the product through the manufacturing process or in the plunger assembly machine.We can ensure that the probability of finding this kind of defect is an isolated issue and any recurrence is really unlikely in our products since review syringe dhr showed no indication of the alleged defect, considering our in-coming and in-process inspection and since this is the first time this lot is reported for this defect, no actions are required.

Event Description

It was reported that air leaked into the bd¿ syringe barrel during blood withdrawal.There was no report of exposure, injury, or medical intervention noted.

• Brand Name: BD¿ SYRINGE
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga
• MDR Report Key: 7704751
• MDR Text Key: 114725997
• Report Number: 3002682307-2018-00176
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup,Followup
• Report Date: 08/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 10/31/2022
• Device Catalogue Number: 301942
• Device Lot Number: 1711217
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2018
• Date Manufacturer Received: 06/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other