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

Catalog Number 300629

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/07/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4) manufacture there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in (b)(4) has been listed in sections and the (b)(4) fda registration number has been used for the manufacture report number.

Event Description

It was reported that during use a unspecified bd syringe malfunctioned as the nurse had difficult hub disengagement.There was no report of exposure, injury or medical intervention needed.

Manufacturer Narrative

Investigation results: one unused 20 ml ll sample without the blister was received by our quality team for investigation.Upon visual inspection of the sample received, it was verified that the plunger of the syringe is damaged on the rod and plunger ridges, generating particles.A device history record could not be evaluated as the lot number is unknown.The root cause of this incident is related to plunger damage during the manufacturing process.Based on severity and occurrence no formal capa is required according to internal procedure.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that during use a bd plastipak¿ syringe malfunctioned as the nurse had difficult hub disengagement.There was no report of exposure, injury or medical intervention needed.

Manufacturer Narrative

Describe event or problem: it was reported that during use a bd plastipak¿ syringe malfunctioned as the nurse had difficult hub disengagement.There was no report of exposure, injury or medical intervention needed.Medical device brand name: bd plastipak¿ syringe, medical device manufacturer: (b)(4), medical device catalog #: 300629, unique identifier (udi) #: (b)(4), manufacturing location: san agustin de guadalix.

• 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 NJ 07417
• MDR Report Key: 7370870
• MDR Text Key: 103691752
• Report Number: 2243072-2018-00161
• 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: 04/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 300629
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 03/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other