MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE

Catalog Number 300865

Device Problem Difficult to Advance (2920)

Patient Problem Cardiopulmonary Arrest (1765)

Event Date 05/01/2018

Event Type  Injury  

Manufacturer Narrative

Initial reporter phone and fax#: (b)(6).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 during medication injection, the plunger movement of a bd plastipak¿ concentric luer lock syringe was difficult, resulting in an adverse event of ¿rhythmic disorders and cardiorespiratory arrest¿.There was no report of medical interventions and no additional information has been able to be obtained at this time.

Manufacturer Narrative

Investigation summary: no sample or picture has been received for investigation.Dhr of lot 1801250 has been reviewed not finding any annotation or deviation regarding the alleged defect.Ten retained samples of 50ll lot 1801250 are evaluated.On visual inspection of these ten retained samples no damage no damage or molding defect can be observed in it.Silicone content test and break out-sustaining force tests are done during manufacturing process per lot according to procedures.On checking the results for these tests on lot 1801250 they are within specification limits.Silicone content test and break out-sustaining force tests are done with the ten retained samples according to procedures.Results meet specification limits previously mentioned.Final products in this manufacturing line, for this reference and lot size are sampled and they are subjected to visual and functional inspections during the different manufacturing sub-processes according to procedures.Visual inspection: molding: 2 injections per shift.Printing: 32 samples per two hours, after any intervention in the equipment and once at the beginning of the shift.Assembly: 32 samples per two hours, after any intervention in the equipment and once at the beginning of the shift.Primary packaging: 1 advance-step (without product) per two hours, after any intervention in the equipment, and once at the beginning of the shift.Secondary packaging: 1 shelf-package per pallet.Functional inspection: printing: once in the first pallet and once in last pallet of the lot.Assembly: once in the first pallet and once in last pallet of the lot.Primary packaging: once in the first pallet and once in last pallet of the lot.Investigation conclusion: since no issues were identified during manufacturing process and manufacturing record established that all production and quality processes were carried out normally and samples evaluated meet specification limits, we can confirm that the root cause of the non-conformance is not related to a manufacturing defect.

• Brand Name: BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 7545063
• MDR Text Key: 109283217
• Report Number: 3003152976-2018-00221
• 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
• Report Date: 06/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/31/2022
• Device Catalogue Number: 300865
• Device Lot Number: 1801250
• Date Manufacturer Received: 05/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other