MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL SYRINGE 20ML LL S/C 48; PISTON SYRINGE

Catalog Number 302830

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/03/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).

Event Description

It was reported that syringe 20ml ll s/c 48 had foreign matter.The following information was provided by the initial reporter: foreign matter.

Manufacturer Narrative

H6.Investigation: a device history record review was completed for provided material number 302830 and lot number 0216660.The review did not reveal any detected quality issues during the production process that could have contributed to this reported defect.To aid in the investigation, one sample and one photo were received for evaluation by our quality team.A visual inspection was performed.The sample came in a sealed packaging blister.The inner side of the bottom packaging web and the inner side of the packaging top web have black spots.The black spots were easily removed with an alcohol wipe concluding the black spots were black ink.The photo provided shows the sample received.It could be possible for this defect to occur if the ink printer had an accumulation of ink that ended up on the packaging webs.Based on the investigation with the returned sample and photo sample analysis the symptom reported by the customer is confirmed.H3 other text : see h10.

Event Description

It was reported that syringe 20ml ll s/c 48 had foreign matter.The following information was provided by the initial reporter: foreign matter.

• Brand Name: SYRINGE 20ML LL S/C 48
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 11389256
• MDR Text Key: 260933253
• Report Number: 1911916-2021-00171
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903028306
• UDI-Public: 00382903028306
• Combination Product (y/n): N
• PMA/PMN Number: K980987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 03/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 302830
• Device Lot Number: 0216660
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2021
• Date Manufacturer Received: 03/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1