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

Catalog Number 300629

Device Problem Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/13/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.(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 the plunger on a bd plastipak¿ syringe was difficult to push causing possible dosage errors.There was no report of injury or medical interventions.

Manufacturer Narrative

Investigation conclusion: no physical samples or picture samples displaying the condition reported were available for examination.We were unable to fully investigate this incident.Ten retained samples of 20ll of lot 1801260 are evaluated.Upon visual inspection of these 10 retained samples, no damage or molding defect can be observed in them that could be related to the alleged defect.Dhr of lot 1801260 is reviewed not finding any annotation or deviation regarding the alleged defect.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¿ SYRINGE
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 7478269
• MDR Text Key: 107593796
• Report Number: 3003152976-2018-00179
• 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: 06/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2018
• 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: 300629
• Device Lot Number: 1801260
• Date Manufacturer Received: 04/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other