MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED PMCF SYRINGE; PISTON SYRINGE

Catalog Number UNKNOWN

Device Problems Break (1069); Leak/Splash (1354); Volume Accuracy Problem (1675); Packaging Problem (3007)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/14/2021

Event Type  malfunction  

Manufacturer Narrative

"unknown manufacturer: 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 and the (b)(4) fda registration number has been used for the manufacture report number.Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Initial reporter phone: (b)(6).A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).

Event Description

It was reported that up 49 unspecified pmcf syringes had one or more of the following defects before or during use: leakage (10), plunger rod damaged (10), damaged (10), scale marking issues, volumetric accuracy (12), damaged packaging (7).The following was reported by the initial reporter: "it was reported via survey response that the clinician encountered leakage from cracked syringe (6), broken / damaged plunder rod (6), open packaging (3), questionable volumetric accuracy (8) and packaging difficult to open / tears (4) related to luer lok and luer slip tip syringes as well as leakage from cracked syringe (4), scale marking issue (3), broken / damaged plunger rod (4), difficulty drawing fluid / medication into syringe (2) and questionable volumetric accuracy (4) related to catheter tip syringes.Additional info related to leakage with luer lok and luer slip tip syringe states: what fluid leaked: local anaesthetic, physiological saline, enteral feeding solution, biologic liquid (ascites and pleural liquid).Where did the leakage come from: the syringe plunger is not waterproof, the body of the syringe is cracked.Additional info related to leakage with catheter tip syringe states: what fluid leaked: biologic liquids (ascites, pleural liquid, bone marrow).Physiological saline.Where did the leakage come from: plunger is defective.Body of the syringe is cracked.".

Event Description

It was reported that up 49 unspecified pmcf syringes had one or more of the following defects before or during use: leakage(10), plunger rod damaged(10), damaged(10), scale marking issues, volumetric accuracy(12), damaged packaging(7) the following was reported by the initial reporter: "it was reported via survey response that the clinician encountered leakage from cracked syringe (6), broken / damaged plunder rod (6), open packaging (3), questionable volumetric accuracy (8) and packaging difficult to open / tears (4) related to luer lok and luer slip tip syringes as well as leakage from cracked syringe (4), scale marking issue (3), broken / damaged plunger rod (4), difficulty drawing fluid / medication into syringe (2) and questionable volumetric accuracy (4) related to catheter tip syringes.See attached excel file for full details.Additional info related to leakage with luer lok and luer slip tip syringe states: what fluid leaked: local anaesthetic, physiological saline, enteral feeding solution, biologic liquid (ascites and pleural liquid).Where did the leakage come from: the syringe plunger is not waterproof, the body of the syringe is cracked.Additional info related to leakage with catheter tip syringe states: what fluid leaked: biologic liquids (ascites, pleural liquid, bone marrow).Physiological saline.Where did the leakage come from: plunger is defective.Body of the syringe is cracked.".

Manufacturer Narrative

H.6.Investigation: bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided.Dhr could not be performed due to unknown lot#.The complaint is unconfirmed and the root cause could not be determined.See h.10.

• Brand Name: UNSPECIFIED PMCF SYRINGE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 11307254
• MDR Text Key: 265895148
• Report Number: 2243072-2021-00282
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: NA
• 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: 02/11/2021

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: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/14/2021
• Initial Date FDA Received: 02/10/2021
• Supplement Dates Manufacturer Received: 02/11/2021
• Supplement Dates FDA Received: 02/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1