MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD INTEGRA 3 ML SYRINGE W/ DETACHABLE NEEDLE; PISTON SYRINGE

Catalog Number 305272

Device Problems Leak/Splash (1354); Failure to Deliver (2338)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/05/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 7271525.Medical device expiration date: 2022-08-31.Device manufacture date: 2017-09-28.Medical device lot #: unknown.Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.

Event Description

Material no.305272, batch no.7271525 possible lots for 2nd issue 8239999 or 7271525.It was reported that during use of the bd integra¿ 3 ml syringe w/ detachable needle had two issues.One was that the product exploded and another it would not retract.The following information was provided by the initial reporter: it was reported that the product exploded and another would not retract.

Manufacturer Narrative

Additional information: a sample was returned from an additional batch.D.4.Medical device lot #: 8239999, d.4.Medical device expiration date: 07/31/2023 and h.4.Device manufacture date: 8/27/2018.H.6.Investigation summary: three integra syringes inside opened blister packs were received and evaluated.Two were from batch 7271525 and one was from batch 8239999.It was observed all three syringes contained clear droplets.Two syringes appeared to activate at the 0.3ml marking and the cutter was unable to reach the hub to retract the needle.One syringe did not have a needle attached but the cutter was exposed through the stopper.Based on the verbatim provided it appears excess force was applied during injection causing the cutter to activate early.As for the hub separating from the syringe it appeared it was not tightened properly.The needle retracted on all the samples received when the thumb rest was pressed.Potential root cause for the premature activation defect is associated with customer training.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number (s) that could have contributed to the reported defect.

Event Description

Material no.305272 batch no.7271525 possible lots for 2nd issue 8239999 or 7271525.It was reported that during use of the bd integra¿ 3 ml syringe w/ detachable needle had two issues.One was that the product exploded and another it would not retract.The following information was provided by the initial reporter: it was reported that the product exploded and another would not retract.

• Brand Name: BD INTEGRA 3 ML SYRINGE W/ DETACHABLE NEEDLE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 9105045
• MDR Text Key: 194398672
• Report Number: 1213809-2019-00957
• Device Sequence Number: 1
• Product Code: MEG
• UDI-Device Identifier: 30382903052722
• UDI-Public: 30382903052722
• Combination Product (y/n): N
• PMA/PMN Number: K011103
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 10/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 305272
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2019
• Date Manufacturer Received: 09/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other