MAUDE Adverse Event Report: BECTON DICKINSON SYRINGE 2ML W/21X1.5 INDIA; PISTON SYRINGE

Catalog Number 301525

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/30/2021

Event Type  malfunction  

Manufacturer Narrative

The manufacturing location for this product is (b)(4).This site is not registered with the fda.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.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 syringe 2ml w/21x1.5 india batch information on the label was overprinted, making it illegible.The following information was provided by the initial reporter: "batch overprinting detail on one carton of the bd syringe is not available.".

Manufacturer Narrative

H6: investigation summary: the photos were received by bd for evaluation.A quality engineer was able to review the photo of an emerald 2ml from lot # 0337482 regarding item # 301525 with the reported issue of ¿batch overprinting detail on one carton of the bd syringe is not available¿.The dhr of material number 301525 and lot number 0337482 was checked and no quality notification was recorded on this lot.No samples and three photographs were received from the customer and were used for investigation of the reported defects.The defect is confirmed.This issue can be caused in secondary packaging while manual packaging, sometimes shelf pack get damaged during transferring from buffer shelf pack to strip filling.H3 other text : see h10.

Event Description

It was reported that the syringe 2ml w/21x1.5 india batch information on the label was overprinted, making it illegible.The following information was provided by the initial reporter: "batch overprinting detail on one carton of the bd syringe is not available.".

• Brand Name: SYRINGE 2ML W/21X1.5 INDIA
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12535981
• MDR Text Key: 273646803
• Report Number: 2243072-2021-02397
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 301525
• Device Lot Number: 0337482
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1